Technical Author - England - Envair Limited

Description

We are currently looking for a Technical Authorto join our growing team in Heywood on a permanent contract.

As a Technical Author, you will be part of a team in our long-established business, delivering projects and developing market leading solutions that benefit our extensive client base.

This is a full-time and permanent role.

The Benefits

• Annual salary £40,000 – 45,000
• Annual bonus based on company performance
• Simply Health cash back plan
• Credit Union
• Nursery voucher salary sacrifice scheme.

Location

Our clean, bright 63,000 sq. ft. site in Heywood, Lancashire is the largest containment factory in the North West, just minutes from the M66 and M62. We have invested £1m in our facility, with state-of-the-art machinery and excellent staff facilities including showers, canteen and plenty of on-site parking.

About us

Envair Technology have been manufacturing world class clean air and containment equipment for the healthcare and pharmaceutical industries since 1972. Our mission is to engineer controlled environments that keep people and products safe from airborne hazards.

Our products, including isolators, laminar airflow cabinets and microbiological safety cabinets, are used to prepare chemotherapy treatments for cancer patients, discover new therapies for Alzheimer's or test samples in hospitals. It means you'll always finish the day feeling you've contributed to something really valuable, supporting our NHS and private hospitals throughout Europe.

We've enjoyed strong growth in demand for our products for the last few years, and as industry leaders, are always looking to bring new innovations to the market. It's why we look for people who share our values of taking pride in your work, being ambitious and inventive, nurturing the people around you and collaborating as a team.

Your Role

As our Technical Author, you will work for the Compliance Engineer and be responsible for producing high-quality validation, compliance, and technical documentation to support the design, manufacture, and regulatory assurance of the company's products. You will:

• Prepare the required validation documentation including the Requirements Traceability Matrices, Design Qualifications, Factory Acceptance Tests, Installation and Operation Qualifications, Operator Manuals, Risk Assessment and Method Statements.
• Produce Standard Test Protocol's and procedure manuals.
• Work closely with the Compliance Engineer to scope out and implement continuous improvement in the production and management of validation documentation.
• Liaise directly with other areas of the business such as the Production, Customer Care, Sales, and After Market departments on behalf of the Engineering Team.
• Work according to the applicable protocols, guidelines and legal standards as required.
• Work with our customers to understand their requirements and respond to their requests for compliance information.
• Monitor and report on new and updated regulations and standards and their impacts on the company's products.

About You

We are looking for someone with the following attributes:

• A degree qualification or equivalent, or experience in a compliance role in a similar industry
• Knowledge of medical/pharmaceutical validation requirements (desirable)
• A proven track record in the development and execution of validation protocols such as risk assessments, design qualifications, FAT, IQOQ, and Operator Manuals or similar
• Working knowledge of CE, UKCA compliance and any associated directives; including but not limited to Low Voltage, EMF, and ATEX
• Experience working under GMP (desirable but not essential)
• Strong team player with excellent communication skills, both written and verbal
• High attention to detail and commitment to accuracy
• Proactive, analytical, and able to work with minimal supervision
• Comfortable working within regulated environments

Envair Technology are an equal opportunities employer. We value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.

Apply for this job

If you can see yourself in this position, send us your CV using the form below. If we think you have the talents we're looking for, we'll be in touch within 10 working days.

I agree for my data to be stored in accordance with the privacy policy.